FDA 510(k)

Disposable Syringe with Needle

Número K: K211482 · 2022-01-24

RequerenteShandong Qinkai Medical Industry Co., Ltd.

Data da decisão2022-01-24

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Qinkai Medical Industry Co., Ltd.. It received FDA 510(k) clearance on 2022-01-24 under 510(k) number K211482. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Syringe with Needle?

Disposable Syringe with Needle is a medical device that received FDA 510(k) clearance on 2022-01-24. The listed applicant is Shandong Qinkai Medical Industry Co., Ltd.. The 510(k) number is K211482.

When did Disposable Syringe with Needle receive FDA 510(k) clearance?

Disposable Syringe with Needle received FDA 510(k) clearance on 2022-01-24, under 510(k) number K211482.

Who is the listed applicant for Disposable Syringe with Needle?

The FDA 510(k) record lists Shandong Qinkai Medical Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Syringe with Needle?

The FDA product code for Disposable Syringe with Needle is FMF.

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Fonte oficial

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